3/14/2023

speaker
Jack
Call Moderator

thank you for holding and welcome everyone to the agennis fourth quarter and full year 2022 financial results conference call all lines have been placed on mute to prevent any background noise after the speaker's remarks there will be a question and answer session if you'd like to ask a question during this time simply press star followed by the number one on your telephone keypad if you'd like to withdraw your question again press the star one thank you i will now turn the call over to zach head of investor relations Zach, please go ahead.

speaker
Zach
Head of Investor Relations

Thank you, Jack, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. Joining me today are Dr. Garo Arman, Chairman and Chief Executive Officer, Dr. Stephen O'Day, Chief Medical Officer, and Christine Klaskin, Vice President of Finance. Now, I'd like to turn the call over to Garo to highlight our progress and speak to our outlook for the remainder of the year. Garo.

speaker
Dr. Garo Arman
Chairman & Chief Executive Officer

Good morning, everyone. And thank you for joining us this morning. We are absolutely thrilled to share the progress we've made at Agenis in advancing our deep immuno-oncology pipeline. Our portfolio is designed to address areas of high patient need and to unlock the large untapped market opportunity in cold and treatment resistant cancers. And on top of that, to provide benefit beyond what is currently available with IO treatments in other tumors, including hot tumors. At the forefront of our pipeline is Botansilumab, a clinical stage, multifunctional, FC-enhanced CTLA for anybody with potentially blockbuster capabilities. Over the last 12 months, we've made substantive progress advancing the ongoing Botanical Imap Development Program, including having dosed over 300 heavily pretreated patients with advanced solid tumors as part of our Phase 1B trial. That's a very large trial by any account. And we've done this with ezmonotherapy and in combination with our PD-L1, I'm sorry, PD-1 antibody, Fosfilumab. Well, Fosfilumab has produced durable, objective responses in nine cold and or treatment-resistant cancers, including MSS colorectal cancer. And MSS stands for microcephalic stable cancers. that are particularly challenging to treat with immunotherapy. So we've seen results in MSS colorectal cancer, MSS endometrial cancer, platinum resistant refractory ovarian cancer, PD-1 resistant refractory non-small cell lung cancer, PD-1 and CTLA-4 resistant refractory melanoma, a particularly challenging patient population, PD-1 resistant refractory hepatocellular carcinoma, PD-1 resistant refractory cervical cancer, angiosarcoma, and liposarcoma. This is a very extensive list of difficult to treat cancers that have been treated and failed prior treatments. Based on the unprecedented clinical responses in these patients, we have initiated three global randomized research trials evaluating the efficacy and safety of botanosilumab monotherapy or combination therapy with bostilumab in MSS colorectal cancer, melanoma, and pancreatic cancer. We aim to initiate a phase three study in MSS colorectal cancer later on this year in the hope that the cumulative data that we've generated between phase one, the phase two randomized trials, and the initiation of our phase three trials will lead to a rapid approval path for the benefit of the patients. We are thrilled by the clinical results we have seen with Potentiolumab and are excited about its potential to positively impact the treatment landscape for patients, obviously, suffering from cancer, all kinds of cancers. We remain committed to advancing our pipeline of innovative therapeutics and believe that our portfolio of programs in the immunology space is robust with multiple programs in development, including Very importantly, our ILT2 program, which is codenamed AGEN1571, and our CD137 program, otherwise also known as 41BB, agonistic antibody, which is codenamed AGEN2373. Both of these molecules are progressing in the clinic. We look forward to sharing more updates on our progress during various conferences throughout this year, and our other communication means as well, again, throughout this year. Thank you for your attention, and now I will turn the call over to Steven O'Dea to highlight the recent clinical data presented on botanical map. Dr. O'Dea has a very extensive section today, because there's a lot to talk about. And so we'll ask him to go through it very, very orderly, slowly, because I think the content is something that is not to be rushed. Dr. O'Day. Thank you, Gero.

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